The present invention relates to systems and methods for irrigation and/or drainage of an open or closed body cavity in human or veterinary medicine using a syringe having at least three selectable ports to allow at least three phases of an irrigation process to be performed in a closed system. Such multiphase syringe systems and methods could be used in conjunction with an indwelling urinary catheter that is passed through the urethra or the abdomen into the bladder. It could be used for gastrointestinal purposes for nasogastric tube irrigation, medical feeding and rectal tube applications. It could also be used in other medical applications that require irrigations, infusions, instillation, or drainage of various materials or medications.
In the medical field, irrigation of various body cavities is used to introduce medical therapy or remove/drain various matter such as blood products, mucous, gastrointestinal material, abscess fluid, ear wax, and genitourinary material. Urinary tract surgeries, such as prostate surgery or trans-urethral resection, typically require the insertion of an indwelling urinary catheter to irrigate and drain the bladder. One example of a device that can be used in such surgical procedures is a urinary catheter. A suprapubic catheter that is inserted through the abdomen into the bladder is another example. Cavities other than the bladder can be irrigated, drained, and/or instilled with other medical therapies in a similar fashion. One example would be nasogastric intubation into the stomach.
Catheters can have multiple lumens (i.e. channels) connecting a body cavity with the outside world. For example, when using a two-lumen urinary catheter for irrigation, one lumen is used for inflating an internal retention balloon and a second lumen can be used for irrigation and drainage. In this configuration, one end of this second lumen would be located in the body cavity and the other end would typically be detachably connected to a manually operated piston syringe for filling, instilling, irrigation, and drainage—a process known as manual (or hand) irrigation. The manual irrigation process typically involves the following steps:    (a) filling the syringe with an irrigating (clean or sterile) solution by placing the tip of the syringe into a container of the solution while manually retracting the piston;    (b) placing the tip of the syringe onto the end of the second lumen of the catheter;    (c) filling the bladder with the irrigating solution by emptying the contents of the syringe into the cavity;    (d) using the syringe to withdraw the material to be flushed (irrigating solution plus blood clots, debris, purulent material, and/or accumulated body tissue) from the bladder;    (e) removing the syringe from the second lumen of the catheter;    (f) emptying the bladder contents from the syringe into a waste container; and    (g) repeating the process as often as necessary, which means the system is opened repeatedly, exposing the catheter lumen and the clean or sterile input fluid to environmental contaminants.
A three-lumen urinary catheter has three channels that can connect to the body cavity. In one configuration, the first lumen is used for the internal retention balloon and the second lumen can be used for performing the same manual irrigation steps that were described for the two-lumen catheter. The third lumen in this configuration can be used for continuous gravity filling of the cavity with an irrigating solution. In another configuration of a three-lumen urinary catheter, the first lumen is for the internal retention balloon, the second is for continuous gravity filling of the cavity with an irrigating solution, and the third is for continuous gravity drainage of the cavity, a configuration called continuous bladder irrigation. The three-lumen urinary catheter system could be converted from the first configuration (manual irrigation) to the second configuration (continuous irrigation) by removing the syringe and replacing it with a line for providing continuous gravity drainage.
The most common systems and methods currently being used for irrigating a bladder require that the system must be opened, or broken repeatedly while irrigating, or when medicine or materials need to be instilled or infused, or when a three-lumen urinary catheter must be changed from manual irrigation to continuous irrigation. Opening an irrigation circuit creates a risk of infection or contamination of the body cavity being irrigated. It can contaminate the clean input fluid source. It can also cause spillage of the input fluid source or drained material, which poses a risk of infecting or contaminating the patient, the operator performing the irrigation, and/or the surrounding equipment and facility. It is desired to have a simple, cost effective, and easy to use closed system that reduces the risk of spillage and contamination. Such a system should also maintain sterility, especially when intermittent irrigation is needed or when manual irrigation is needed during continuous irrigation. Ideally, the system would reduce the risk of catheter or drain associated infections, reduce staffing time needed to clean the spillage from manual irrigation. The system should also reduce the risk of contamination of the cavity, the tubing system, the input fluid source, the patient, any staff member, other patients, and any surrounding equipment and the facility where the system is located. A well-designed system could be left in place for an entire duration/hospitalization for intermittent manual irrigation, whether continuous irrigation is needed or not. Such a system could be used for on-demand manual irrigation with either a two-lumen or a three-lumen urinary catheter. The system could have a manually operable plunger that could have a limiter and a locking mechanism that sets the plunger into a partially open position in the barrel. This locking mechanism could prevent inadvertent insertion or retraction of the plunger in the barrel. The partially open position allows for continuous drainage through the barrel. A simple, cost-effective, and easy-to-use system that doesn't need to be opened, could also be fastened to the patient or in the vicinity of the cavity to prevent tension or dislodging of the syringe from the circuit. The system could be latex free. The system could have universal application. The system could include other features such as the use of bacteriostatic or antibacterial coating on part or all of the system. The system could include a splashguard to minimize spillage if the system is accidentally opened. The system could include a catheter tip fastener that locks the catheter lumen to a catheter port or line on an irrigating device to prevent accidental dislodging of the catheter tip and urinary catheter connection.